Regulatory Outlook on Data Management

In a recent video interview with Applied Clinical Trials, Erin Erginer, director of product, Certara discussed the growing complexity and volume of data in clinical trials. Data is now captured from biospecimens and digital health technologies, including advanced genetic and imaging data. Regulatory agencies require standardized data submission for analysis, but do not dictate collection methods, leaving pharma companies to develop their own standards. Lack of standards leads to inefficiencies, with only 20% of studies meeting deadlines, causing significant delays and costs. Improper data collection can lead to missed endpoints and regulatory issues. Collaboration among pharma companies and external vendors is crucial for improving data standards and trial efficiency.

A transcript of Erginer’s conversation with ACT can be found below.

ACT: Looking forward, what are some actions you would like to see regulatory bodies take to address the challenges we’ve discussed?

Erginer: Well, I think that regulatory agencies have done a good job ensuring that the teams are using those submission standards and requiring that data integrity and being able to demonstrate how your workflow is going through, but I really do think that it comes down the remit of the pharma industry to be able to collaborate internally with each other and work together along with the external vendor data providers in order to create those data standards that can be used. Really solving this problem is going to mean that you are going to begin able to conduct trials more efficiently and ultimately get the drugs to the patients as they need them.